BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cross-Sectional Mammographic Xray System

    PMA: P130025 · Supplement: S003 · Decision Oct 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Cross-Sectional Mammographic Xray System
    Trade Name
    Koning Breast CT, KBCT
    PMA Number
    P130025
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    OLQ
    Generic Name
    Cross-sectional mammographic xray system
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 24, 2017
    Date Received
    September 5, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the input power requirements to 210-240 VAC, 30 AMP service and software changes associated with an added light switch, camera and touch screen interface.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLQ Cross-Sectional Mammographic Xray System